A diverse portfolio of topical skin medications
TWYNEO®Tretinoin and Benzoyl Peroxide Cream, 0.1%/3% Acne Vulgaris | research | pre-clinical | phase Ⅰ | phase ⅠⅠ | phaseⅠⅠⅠ | FDA approved | Galderma Partnership in US |
EPSOLAY®Benzoyl Peroxide Cream, 5% Inflammatory Lesions of Rosacea | research | pre-clinical | phase Ⅰ | phase ⅠⅠ | phase ⅠⅠⅠ | FDA approved | Galderma Partnership in US |
SGT-610Patidegib gel, 2% Gorlin Syndrome | research | pre-clinical | phase Ⅰ | phase ⅠⅠ | phaseⅠⅠⅠ planned H2/2023 | FDA Approved | |
SGT-210Topical Erlotinib Pachyonychia Congenita and Other Rare Skin Indications | research | pre-clinical | phase Ⅰ ongoing | phase ⅠⅠ | NDA submission | FDA Approved |
Our Microencapsulation Technology
EPSOLAY®
EPSOLAY is FDA approved topical cream containing benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY utilizes proprietary technology in order to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. EPSOLAY is protected by granted patents until 2040.
*Not an actual patient – actor portrayal
*Not an actual patient – actor portrayal
EPSOLAY®
EPSOLAY is an investigational topical cream containing benzoyl peroxide, 5%, under FDA review for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY utilizes proprietary technology in order to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. EPSOLAY is protected by granted patents until 2040. The FDA is expected to conduct a pre-approval inspection of the production site for EPSOLAY during the week of February 14th, 2022.
The safety and efficacy of Epsolay have not been established.
Epsolay is a registered trademark of Sol-Gel Technologies, Ltd.
*Not an actual patient – actor portrayal
TWYNEO®
TWYNEO is FDA approved topical cream containing a fixed-dose combination of tretinoin and benzoyl peroxide, 0.1%/3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. Tretinoin and benzoyl peroxide have a complementary mechanism of action and are widely prescribed separately for acne vulgaris; however, no combination of the two, other than TWYNEO, has been approved by the FDA because benzoyl peroxide decomposes tretinoin rapidly – so patients cannot use both drugs concomitantly. TWYNEO utilizes a proprietary technology to encapsulate both benzoyl peroxide and tretinoin within silica-based microcapsules to prevent the decomposition of tretinoin by benzoyl peroxide and to reduce the irritation associated with both active substances. TWYNEO is protected by granted patents until 2038.
SGT-610
SGT-610 (patidegib) gel, 2%, is currently being developed by Sol-Gel for the prevention of new BCCs in GS patients. We expect to initiate Phase 3 in the 2nd half of 2023.
Patidegib is a new hedgehog inhibitor (HHI) blocker aimed to prevent new BCCs without the systemic adverse events of oral HHIs. It has been granted Orphan Drug Designation by the FDA and the EMA as well as Breakthrough Designation by the FDA. Both FDA and EMA have agreed that approval will be supported by a single pivotal Phase 3 study*.
* Granted to previous sponsor – PellePharm Inc.
SGT-210
SGT-210 (erlotinib) is a topical drug candidate for the treatment of pachyonychia congenita and other hyperkeratosis indications. Erlotinib is a tyrosine kinase receptor inhibitor which acts on the epidermal growth factor receptor, a protein expressed on the surface of cells, whose job is to help cells grow and divide. There is a case report showing that orally administered erlotinib improved the quality of life of pachyonychia congenita patients but was associated with significant adverse events, while topically applied erlotinib, 0.2%, failed to display significant improvement1. Sol-Gel’s scientists have managed to overcome erlotinib formulation limitations and developed a topical product with a significantly higher concentration of erlotinib than that which was reported to be inefficient. SGT-210 is expected to treat pachyonychia congenita without the adverse events caused by oral erlotinib. Our Phase-1 was initiated in December 2022.